Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery

May 18, 2010 updated by: Fresenius Kabi

Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)

The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands
        • Medical Center Alkmaar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR)
  • preoperative radiotherapy (5x5 Gy) or chemoradiation
  • loop ileostoma or colostoma;

Exclusion Criteria:

  • severe malnutrition
  • severe renal insufficiency
  • diabetes mellitus I or II
  • concomitant thyroid medication
  • corticosteroids
  • diuretic medication and antihypertensive medication
  • known or suspected allergy to any component of the investigational product(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Oral nutritional supplement: assignment according to consecutive random numbers.
Dietary supplement: PreOP Booster (food for special medical purposes)
3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;
Placebo Comparator: Control
Assignment according to consecutive random numbers.
Dietary supplement: PreOP Booster (food for special medical purposes)
3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunoinflammatory parameters
Time Frame: on day -2, -1, 1, 2, 3, 5, and 7
on day -2, -1, 1, 2, 3, 5, and 7
Antioxidant / oxidant parameters
Time Frame: on day -2, 1, 3, 5, and 7
on day -2, 1, 3, 5, and 7
Ischemia / reperfusion injury parameters
Time Frame: on day -2, 1, 3, 5, and 7
on day -2, 1, 3, 5, and 7

Secondary Outcome Measures

Outcome Measure
Time Frame
pre-and postoperative discomfort (well-being)
Time Frame: on day -1, and 0
on day -1, and 0
hand grip strength
Time Frame: on day -2, 1, 2, 3, 5, and 7
on day -2, 1, 2, 3, 5, and 7
GI tolerance
Time Frame: on day -1, 0, 1, 2, and 7
on day -1, 0, 1, 2, and 7
Safety
Time Frame: on day -1, 0, 1, 2, 3, 5, and 7
on day -1, 0, 1, 2, 3, 5, and 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Investigators

  • Study Chair: Paul A.M. van Leeuwen, Prof., University Hospital Amsterdam; The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 19, 2010

Last Update Submitted That Met QC Criteria

May 18, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-POB-04-NL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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